Covaxin, the Bharat Biotech's vaccine against the coronavirus disease (Covid-19), has shown efficacy of 77.8% from trial conducted on 25,800 subjects, according to reports.
The efficacy rate came out on Tuesday after DGCI's subject expert committee (SEC) met and discussed the results.
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The pharmaceutical firm had submitted phase 3 trial data for the vaccine to the Drug Controller General of India (DGCI) over the weekend.
The meeting took place before the company's 'pre-submission' meeting on Wednesday with the World Health Organization (WHO).
Covaxin is one of the three vaccines which are currently being used in India. Serum Institute of India's Covishield and Russia's Sputnik V have also been administered to the Indian citizens so far.
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The country is also preparing to use a local version of the Novavax vaccine, which will be produced by the SII. The vaccine was more than 90% effective in a late-stage US-based clinical trial, according to the company.
The phase III data approval of Covaxin, which was developed by the Bharat Biotech in association with the Indian Council of Medical Research (ICMR), is likely to help the firm secure an EUL (emergency use listing) from the WHO.
{{/usCountry}}The phase III data approval of Covaxin, which was developed by the Bharat Biotech in association with the Indian Council of Medical Research (ICMR), is likely to help the firm secure an EUL (emergency use listing) from the WHO.
{{/usCountry}}While Covaxin was undergoing clinical trials, it was cleared for emergency use last year. It was given "restricted use in emergency situation in public interest", which raised questions and was also seen as contributing to vaccine hesitancy that marked the early stages of India's vaccination drive.